erlotinib in post radical operation nsclc patients with egfr mutation

Conditions: Non-small Cell Lung Cancer Stage III

Summary: this study is to compare 2-year disease free survival rate (dfsr) in post radical operation iiia non-small cell lung cancer (nsclc) patients with epidermal growth factor receptor (egfr) 19 or 21 exon mutation treated erlotinib vs np chemotherapy as adjuvant therapy.


Eligibility criteria:
inclusion criteria: * iiia nsclc patients according to tmn-staging of lung staging standard version 7 2009, confirmed by histopathology or cytology after radical operation, and having egfr exon 19 deletion mutation or exon 21 l858r single base substitution; * accept study adjuvant therapy within 6 weeks post radical operation; * ecop ps 0-1; life expectancy ≥12 weeks; * hematology: absolute neutrophil count (anc) ≥1.5×10\^9/l; platelet count ≥100×10\^9/l; hemoglobin concentration ≥ 9.0 g/dl (permit to maintain hematologic criteria by blood transfusion); * liver function: tbil ≤1.5xuln; alt and ast ≤2.5xuln; * renal function: cr ≤1.25xuln, and ccr ≥60ml/min; * female patients of childbearing potential must have a negative serum or urine pregnancy test within 7 days before study treatment; * signed inform consent form by patient or his/her legal representative; * comply with study protocol and procedure, and be able to take oral medication; aged ≥18 years and ≦75 years; * eligible patients of reproductive potential (both sexes) must agree to use a reliable method of birth control before enrollment, during the study period and for at least 30 days after their last dose of study therapy; exclusion criteria: * having treated by her-target therapy, i.e. erlotinib, gefitinib, cetuximab, trastuzumab; * having treated by any systemic anti-tumor therapy of nsclc, including cytotoxic therapy, target medication treatment (i.e. monoclonal antibody), investigational therapy; * having local radiotherapy of nsclc; upper gastrointestinal physiological disorders, or malabsorption syndrome, or intolerance of oral medication, or active peptic ulcer; * the findings in radical operation are lymph nodes with extracapsular invasion, or fusion, or all of dissection lymph nodes positive by pathology; * diagnosed other malignant tumor besides nsclc within 5 years prior the study treatment (except having simple surgical resection with 5-year disease free survival,cured in situ of cervical carcinoma, cured basal cell carcinoma and bladder epithelial tumor); * confirmed recurrent cancer by clinical objective evidence (pathology or radiography images) before the study adjuvant therapy; * known hypersensitivity to platinum, vinorelbine, egfr-tki agents or relevant components in the formulation; * uncontrolled eye inflammation or infection, or any potential circumstances lead to eye inflammation or infection; * active interstitial lung disease (ild) by any clinical evidence; patients with any co-morbidities, or motalic disorders, or any abnormal findings in physical examination or laboratory tests are suspected to have contraindication of study therapy or high risk of study treatment complications; * any unstable systemic disease, including active infection, uncontrolled hypertension, unstable angina, angina starting in latest 3 months, congestive heart failure (nyha ≥ ii), myocardial infarction within 6 months prior enrollment, under medication treatment of severe arrhythmia, liver, renal or metabolic disease; * know hiv infection pregnant or breastfeeding women; * ecog ps ≥2; * mixed with small cell lung cancer; * other conditions investigators evaluate that patient is not eligible to this study.

Keywords: erlotinib adjuvant therapy radical operation iiia nsclc egfr mutation